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This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.
An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years.
There are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUM-201 (1.6 mg/kg/day) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUM-201 | Drug | Administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Number of events | Day 1 to Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Growth Hormone Concentrations in subjects | Serum GH concentration | Day 1 to Month 36 |
| Insulin-like growth factor 1 concentration | Serum concentrations of insulin-like growth factor 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| UMass Memorial Medical Center |
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Open Label
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| Day 1 to Month 36 |
| Height standard deviation score (SDS) | Change in HT-SDS | Day 1 to Month 36 |
| Change in Weight SDS | Change in Weight | Day 1 to Month 36 |
| Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201 | (AHV) measured as standing height with stadiometer | Day 1 to Month 36 |
| Change in Bone Age (BA) | Change in Bone Age (BA) compared to Chronological Age | Day 1 to Month 36 |
| Worcester |
| Massachusetts |
| 01655 |
| United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64111 | United States |
| University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Tech University Health Sciences Center | Amarillo | Texas | 79106 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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